[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of sacubitril-valsartan sodium tablets (100 mg) in Chinese healthy subjects under fasting and postprandial administration conditions

主要研究目的：按有关生物等效性试验的规定，选择Novartis Pharma Schweiz AG为持证商的沙库巴曲缬沙坦钠片（商品名：诺欣妥®，规格：以沙库巴曲缬沙坦计100mg(沙库巴曲49mg/缬沙坦51mg)）为参比制剂，对江苏神华药业有限公司生产并提供的受试制剂沙库巴曲缬沙坦钠片（规格：以沙库巴曲缬沙坦计：100mg(沙库巴曲49mg/缬沙坦51mg)）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂沙库巴曲缬沙坦钠片（规格：以沙库巴曲缬沙坦计100mg：(沙库巴曲49mg/缬沙坦51mg)）和参比制剂沙库巴曲缬沙坦钠片（商品名：诺欣妥®，规格：以沙库巴曲缬沙坦计100mg(沙库巴曲49mg/缬沙坦51mg)）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Novartis Pharma Schweiz AG was selected as the reference preparation for sacubitril-valsartan sodium tablets (trade name: Nuxintu®, specification: 100 mg (sacubitril 49 mg/valsartan 51 mg)) as the licensee, and the test preparation sacubitril-valsartan sodium tablets (specification: 100 mg (sacubitril 49 mg/valsartan 51 mg)) produced and provided by Jiangsu Shenhua Pharmaceutical Co., Ltd. were subjected to fasting and fed human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions. Secondary study objective: To observe the safety of oral administration of the test preparation sacubitril-valsartan sodium tablets (specification: 100 mg of sacubitril-valsartan: (sacubitril 49 mg/valsartan 51 mg)) and the reference preparation sacubitril-valsartan sodium tablets (trade name: Entresto®, specification: 100 mg of sacubitril-valsartan (sacubitril 49 mg/valsartan 51 mg)) in healthy subjects.

Start Date-

Sponsor / Collaborator

Jiangsu Shenhua Pharmaceutical Co., Ltd.

100 Clinical Results associated with Jiangsu Shenhua Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Jiangsu Shenhua Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Jiangsu Shenhua Pharmaceutical Co., Ltd.

01 Sep 2019·International Journal of Biological MacromoleculesQ1 · CHEMISTRY

Structural characterization and anti-alcoholic liver injury activity of a polysaccharide from Coriolus versicolor mycelia

Q1 · CHEMISTRY

Article

Author: Mao, Xiangjunzhi ; Chen, Lu ; Geng, Yan ; Shi, Jin-Song ; Ren, Yilin ; Xu, Guo-Hua ; Xu, Zheng-Hong ; Lu, Zhen-Ming ; Gong, Jin-Song ; Xu, Hong-Yu ; Wang, Kang-Le ; Li, Heng

Polysaccharopeptide (PSP) from the medicinal mushroom Coriolus versicolor has been widely used in Asia as an adjunctive immunotherapy for treating cancers and liver diseases. However, the composition and structure of bioactive components in PSP remain elusive. Herein, we purified a hepatoprotective polysaccharide (PSP-1b1) with a molecular weight of 21.7 kDa from C. versicolor mycelia in submerged culture. PSP-1b1 consists of fucose, galactose, xylose, mannose, glucuronic acid and glucose at a relative molar ratio of 0.16:0.60:0.02:0.55:0.04:1.00. Structural features were investigated by methylation and gas chromatography-mass spectrometry, Fourier transform infrared spectroscopy and nuclear magnetic resonance spectroscopy. The PSP-1b1 backbone consists of →4)-α-Galp-(1 → 4)-α-Galp-(1 → 2)-α-Manp-(1 → 4)-α-Galp-(1 → 2)-α-Manp-(1 → 4)-α-Galp-(1 → 4)-α-Galp-(1 → 2)-α-Manp-(1 → 4)-α-Galp-(1 → 2)-α-Manp-(1 → 4)→, with branches of α-1,6-Manp, β-1,6-Glcp, β-1,3,6-Glcp, α-1,3-Manp, α-1,6-Galp, α-1,3-Fucp, T-α-Glcp and T-α-Galp on the O-6 position of α-Manp of the main chain, and secondary branches linked to the O-6 position of β-Glcp of the major branch. Treatment with PSK-1b1 (80 and 160 mg/kg/day) resulted in hepatoprotective effects against alcohol-induced liver injury in mice by reducing oxidative stress and modulating immunity.

01 Jan 2019·International Journal of Medicinal MushroomsQ4 · BIOLOGY

Therapeutic Effect and Potential Mechanisms of Lion's Mane Medicinal Mushroom, Hericium erinaceus (Agaricomycetes), Mycelia in Submerged Culture on Ethanol-Induced Chronic Gastric Injury

Q4 · BIOLOGY

Article

Author: Mao, Xiangjunzhi ; Xu, Guo-Hua ; Lu, Zhen-Ming ; Shi, Jin-Song ; Gong, Ting-Ting ; Xu, Zheng-Hong ; Wang, Kang-Le ; Xu, Hong-Yu ; Geng, Yan

Hericium erinaceus (HE) is an edible and medicinal mushroom traditionally used for the treatment of gastric injury in clinical practice. However, scientific evidence of its pharmacological activities has not yet been revealed. This study was designed to investigate the therapeutic effect of HE mycelia in submerged culture on ethanol-induced chronic gastric injury (ECGI) in mice. Gastric injury model was induced by ethanol with chronic and binge ethanol feeding in mice, and then mice were treated with HE mycelia. The stomachs were removed for histopathological examination and inflammatory cytokines measurement. Meanwhile, total proteins of gastric tissue were analyzed by isobaric tags for relative and absolute quantification (iTRAQ) labeling analysis to quantitatively identify differentially expressed proteins (DEPs) in three groups of animals. Bioinformatics analysis of DEPs was conducted through clustering analysis, Venn analysis, Gene Ontology (GO) annotation enrichment, and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways enrichment. The histopathologic characteristics and biochemical data showed that HE mycelia (0.5 and 1.0 g/kg) exhibited therapeutic effects on the ECGI mice. Based on the results of iTRAQ analysis, a total of 308 proteins were differentially expressed in the ethanol group when compared with the control group; 205 DEPs in the high dose of HE (HEH) group when compared with control group; and 230 DEPs in HE group (1.0 g/kg) when compared with ethanol group. KEGG analysis showed that the p53 signaling pathway was closely related to the therapeutic effect of HE mycelia on ECGI. Furthermore, the expression levels of several DEPs, including keratin (KRT) 16, KRT6b and transglutaminase E (TGE), were verified by quantitative real-time polymerase chain reaction (qRT-PCR). In conclusion, H. erinaceus mycelia could relieve ethanol-induced chronic gastric injury in mice by ameliorating inflammation as well as regulating epidermal differentiation.

01 Jul 2018·The Journal of Nutritional BiochemistryQ2 · MEDICINE

Polysaccharide of Hericium erinaceus attenuates colitis in C57BL/6 mice via regulation of oxidative stress, inflammation-related signaling pathways and modulating the composition of the gut microbiota

Q2 · MEDICINE

Article

Author: Lu, Zhen-Ming ; Xu, Hong-Yu ; Li, Wang ; Du, Yan ; Shi, Jin-Song ; Xu, Zheng-Hong ; Ren, Yilin ; Geng, Yan ; Xu, Guo-Hua

Inflammatory bowel disease (IBD) is a disease caused by a dysregulated immune with unknown etiology. Hericium erinaceus (H. erinaceus) is a Chinese medicinal fungus, with the effect of prevention and treatment of gastrointestinal disorders. In this study, we have tested the anti-inflammatory effect of polysaccharide of H. erinaceus (HECP, Mw: 86.67 kDa) in the model of dextran sulfate sodium (DSS)-induced colitis in C57BL/6 mice. Our data indicated that HECP could improve clinical symptoms and down-regulate key markers of oxidative stresses, including nitric oxide (NO), malondialdehyde (MDA), total superoxide dismutase (T-SOD), and myeloperoxidase (MPO). HECP also suppressed the secretion of interleukin (IL)-6, interleukin (IL)-1β, tumor necrosis factor (TNF)-α and the expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS) and decreased the expression of related mRNA. Meanwhile, HECP blocked phosphorylation of nuclear factor-κB (NF-κB) p65, NF-κB inhibitor alpha (IκB-α), mitogen-activated protein kinases (MAPK) and Protein kinase B (Akt) in DSS-treated mice. Moreover, HECP reversed DSS-induced gut dysbiosis and maintained intestinal barrier integrity. In conclusion, HECP ameliorates DSS-induced intestinal injury in mice, which suggests that HECP can serve as a protective dietary nutrient against IBD.

100 Deals associated with Jiangsu Shenhua Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Jiangsu Shenhua Pharmaceutical Co., Ltd.

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